Fixation band for affixing a prosthetic heart valve to tissue

ABSTRACT

A prosthetic heart comprising a tube having proximal and distal ends, and a central lumen, a tubular frame having proximal and distal ends, and a central lumen, the tubular frame, comprising a plurality of radially-extending members, being disposed on an outside wall of the tube, the distal end of the tube being everted around the distal end of the tubular frame and extending proximally along the tubular frame and over the radially-extending members, and a valve member attached to the tube.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This application is a Continuation of pending U.S. application Ser. No.12/587,041, filed Oct. 1, 2009, which is a Divisional of U.S.application Ser. No. 11/479,357, filed Jun. 29, 2006, now U.S. Pat. No.7,611,535, which is a Divisional of U.S. application Ser. No.10/414,766, filed Apr. 16, 2003, now U.S. Pat. No. 7,097,659, which: 1)is a Continuation-In-Part of U.S. application Ser. No. 09/949,061, filedSep. 7, 2001, now U.S. Pat. No. 6,846,325; and 2) which claims thebenefit of U.S. Provisional Application No. 60/373,059, filed Apr. 16,2002, the entire disclosures of which are hereby incorporated byreference.

FIELD OF THE INVENTION

This invention relates to surgical apparatus in general, and moreparticularly to prosthetic heart valves.

BACKGROUND OF THE INVENTION

The human heart consists of four chambers: the right atrium forreceiving blood from systemic circulation; the right ventricle forreceiving blood from the right atrium and pumping it to the lungs; theleft atrium for receiving oxygenated blood from the lungs; and the leftventricle for receiving oxygenated blood from the left atrium andpumping it to systemic circulation.

The human heart also consists of four valves: the tricuspid valvelocated between the right atrium and the right ventricle; the pulmonaryvalve located at the output of the right ventricle; the mitral valvelocated between the left atrium and the left ventricle; and the aorticvalve located at the output of the left ventricle.

In some circumstances (e.g., a birth defect, disease, etc.) a naturalheart valve may need to be replaced by a prosthetic heart valve. In thissituation, sometimes referred to as “on pump” surgery, the patient must,be placed on a heart-lung machine and the heart stopped while thedefective heart valve is removed and the prosthetic heart valveinstalled through a major incision made in the wall of the heart. Theprosthetic heart valve is typically sutured in place at the annulus, orseat, of the natural heart valve using a sewing cuff disposed about thecircular periphery of the prosthetic heart valve.

While such surgery is typically successful, it is also highly traumaticto the body and the use of the heart-lung machine may raise issues ofsubtle mental impairment in the near term following surgery.

In view of the trauma associated with a major heart wall incision andpossible subtle mental impairment which may be associated with the useof a heart-lung machine, it has been proposed to effect valvereplacement without placing the patient on a heart-lung machine andstopping the heart. See, for example, PCT Patent Application No.PCT/US00/02126, filed Jan. 27, 2000 by Gregory Lambrecht et al. forCARDIAC VALVE PROCEDURE METHODS AND DEVICES, published Aug. 3, 2000 asPCT Patent Publication No. WO 00/44313. This type of surgery issometimes referred to as “off-pump”, or “beating heart”, surgery.

It has been recognized that if a heart valve is to be replaced with“off-pump”, “beating heart” surgery, the incisions made into thevascular system should be as small as possible. However, this can makeit difficult to secure the prosthetic heart valve in place, since theprosthetic heart valve is typically sutured to the annulus, or seat, ofthe natural heart valve, and since suturing (including knot tying) canbe difficult to effect through small incisions. This can be particularlytrue where the incisions may be made into the vascular system at alocation remote from the valve seat, e.g., in the superior vena cava inthe case of the tricuspid valve, or in the pulmonary artery in the caseof the pulmonary valve, or the pulmonary veins in the case of the mitralvalve, or the aorta in the case of the aortic valve.

SUMMARY OF THE INVENTION

As a result, one object of the present invention is to provide novelapparatus for quickly, easily and conveniently affixing a prostheticheart valve in position within the heart.

Another object of the present invention is to provide a novel fixationband for affixing a prosthetic heart valve in position within the heart.

And another object of the present invention is to provide a novel methodfor affixing a prosthetic heart valve in position within the heart.

These and other objects of the present invention are addressed by theprovision and use of a novel fixation band for affixing a prostheticheart valve in position within the heart.

In one preferred form of the invention, the fixation band generallycomprises a tubular frame having a distal end and a proximal end, and atube having a distal end and a proximal end. The tubular frame comprisesa plurality of longitudinally-extending members each having a hook onits distal end and fixation means on its proximal end. The tubular framealso comprises at least one laterally-extending member for stabilizingthe longitudinally-extending members relative to one another so as toform the complete tubular frame. The tube is positioned inside thelongitudinally-extending members, with the distal end of the tube beingeverted back over the aforementioned hooks. A sewing cuff is formed inthe tube distal to the distalmost end of the longitudinally-extendingmembers.

In use, a standard prosthetic valve is secured to the distal end of thefixation band by suturing the prosthetic valve's sewing cuff to thefixation band's sewing cuff. Next, the prosthetic valve, with fixationband attached, is advanced to the valve's seat. Then the fixation band'stubular frame is pulled proximally slightly. This action causes the endsof the hooks to pass through the side wall of the everted tube and intothe surrounding tissue at the valve's seat, whereby the fixation band,and hence the prosthetic valve, will be fixed against further proximalmovement. Next, the fixation band's fixation means are deployed so as tosecure the proximal end of the fixation band to the surrounding tissue,whereby the fixation band, and hence the prosthetic valve, will be fixedagainst distal movement.

In one form of the invention, the fixation means may be deployed bybending them radially outwardly so that they engage the surroundingtissue.

In another form of the present invention, the fixation means may bedeployed by removing a restraining device, whereby the fixation meanswill automatically deploy against the surrounding tissue.

In another form of the present invention, there is provided a fixationband for affixing a prosthetic heart valve to tissue, the fixation bandcomprising: a structure having a proximal end and a distal end inopposition to one another, and a lateral region between the proximal endand the distal end, wherein the prosthetic heart valve is attached toone of the proximal end and the distal end of the structure; a pluralityof barbs selectively configurable between a first position and a secondposition, the barbs being contained within a peripheral boundary of thelateral region of the structure in the first position, and the barbsbeing extended from the peripheral boundary of the lateral region of thestructure in the second position; and an actuator for selectively movingthe plurality of barbs between the first position and the secondposition.

In another form of the present invention, there is provided a prostheticheart valve assembly comprising: a prosthetic heart valve comprising aframe, at least one leaflet adapted to open and close relative to theframe; and a fixation band for affixing the prosthetic heart valve totissue, the fixation band comprising: a structure having a proximal endand a distal end in opposition to one another, and a lateral regionbetween the proximal end and the distal end, wherein the prostheticheart valve is attached to one of the proximal end and the distal end ofthe structure; a plurality of barbs selectively configurable between afirst position and a second position, the barbs being contained within aperipheral boundary of the lateral region of the structure in the firstposition, and the barbs being extended from the peripheral boundary ofthe lateral region of the structure in the second position; and anactuator for selectively moving the plurality of barbs between the firstposition and the second position.

In another form of the present invention, there is provided a method foraffixing a prosthetic heart valve to tissue, the method comprising:providing a fixation band for affixing a prosthetic heart valve totissue, the fixation band comprising: a structure having a proximal endand a distal end in opposition to one another, and a lateral regionbetween the proximal end and the distal end, wherein the prostheticheart valve is attached to one of the proximal end and the distal end ofthe structure; a plurality of barbs selectively configurable between afirst position and a second position, the barbs being contained within aperipheral boundary of the lateral region of the structure in the firstposition, and the barbs being extended from the peripheral boundary ofthe lateral region of the structure in the second position; and anactuator for selectively moving the plurality of barbs between the firstposition and the second position; positioning the fixation band adjacentto the tissue; and actuating the fixation band so as to affix theprosthetic valve to tissue.

In another form of the present invention, there is provided a method foraffixing a prosthetic heart valve to tissue, the method comprising:positioning a fixation band adjacent to the tissue; and removing a pinin engagement with a spring in a loaded configuration so as to releasethe spring, cause a cog to rotate, and deploy barbs through a lateralportion of the fixation band into the tissue surrounding the fixationband.

In another form of the present invention, there is provided a fixationband for affixing a prosthetic heart valve to tissue, the fixation bandcomprising: a proximal annular portion and a distal annular portionselectively positioned relatively to one another, the proximal annularportion and the distal annular portion each having a proximal side and adistal side, the proximal side of the distal annular portion and thedistal side of the proximal annular portion being oriented toward oneanother, and the prosthetic heart valve being attached to one of thedistal side of the distal annular portion and the proximal side of theproximal annular portion; a plurality of staples configured between thedistal side of the proximal annular portion and the proximal side of thedistal annular portion; and a compression device in attachment to theproximal annular portion and the distal annular portion, the compressiondevice being configured to selectively position the proximal annularmember and the distal annular member toward one another so as tocompress the plurality of staples therebetween and deploy the pluralityof staples into tissue so as to affix the prosthetic heart valve to thetissue.

In another form of the present invention, there is provided a prostheticheart valve assembly comprising: a prosthetic heart valve comprising aframe, and at least one leaflet adapted to open and close relative tothe frame; and a fixation band for affixing a prosthetic heart valve totissue, the fixation band comprising: a proximal annular portion and adistal annular portion selectively positioned relatively to one another,the proximal annular portion and the distal annular portion each havinga proximal side and a distal side, the proximal side of the distalannular portion and the distal side of the proximal annular portionbeing oriented toward one another, and the prosthetic heart valve beingattached to one of the distal side of the distal annular portion and theproximal side of the proximal annular portion; a plurality of staplesconfigured between the distal side of the proximal annular portion andthe proximal side of the distal annular portion; and a compressiondevice in attachment to the proximal annular portion and the distalannular portion, the compression device being configured to selectivelyposition the proximal annular member and the distal annular membertoward one another so as to compress the plurality of staplestherebetween and deploy the plurality of staples into tissue so as toaffix the prosthetic heart valve to the tissue.

In another form of the present invention, there is provided a method foraffixing a prosthetic heart valve to tissue, the method comprising:providing a fixation band for affixing a prosthetic heart valve totissue, the fixation band comprising: a proximal annular portion and adistal annular portion selectively positioned relatively to one another,the proximal annular portion and the distal annular portion each havinga proximal side and a distal side, the proximal side of the distalannular portion and the distal side of the proximal annular portionbeing oriented toward one another, and the prosthetic heart valve beingattached to one of the distal side of the distal annular portion and theproximal side of the proximal annular portion; a plurality of staplesconfigured between the distal side of the proximal annular portion andthe proximal side of the distal annular portion; and a compressiondevice in attachment to the proximal annular portion and the distalannular portion, the compression device being configured to selectivelyposition the proximal annular member and the distal annular membertoward one another so as to compress the plurality of staplestherebetween and deploy the plurality of staples into tissue so as toaffix the prosthetic heart valve to the tissue; positioning the fixationband adjacent to the tissue; and actuating the compression device so asto move the proximal annular portion and the distal annular portiontoward one another so as to deploy the plurality of staples into thetissue.

In another form of the present invention, there is provided a method foraffixing a prosthetic heart valve to tissue, the method comprising:positioning a fixation band having the prosthetic heart valve attachedthereto adjacent to the tissue; and actuating a compression deviceattached to the fixation band so as to move a proximal annular portionand a distal annular portion of the fixation band toward one another soas to deploy a plurality of staples into the tissue.

In another form of the present invention, there is provided a method foraffixing a prosthetic heart valve to tissue, the method comprising:positioning a fixation band adjacent to tissue; actuating a compressiondevice attached to the fixation band to move a proximal annular portionand a distal annular portion of the fixation band toward one another soas to deploy a plurality of staples into the tissue; and attaching theprosthetic heart valve to the fixation band.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts and further wherein:

FIG. 1 is a schematic view of a fixation band formed in accordance withthe present invention;

FIG. 2 is a schematic view of the fixation band's tubular frame;

FIG. 3 is a schematic view of the fixation band's tube prior itsassembly with the tubular frame;

FIG. 4 is a schematic view of the complete fixation band shown in FIG.1;

FIG. 5 is a schematic view showing a prosthetic heart valve secured tothe fixation band of FIG. 1;

FIG. 6 is a schematic view showing the assembly of FIG. 5 afterdeployment of the fixation band's distal hooks;

FIG. 7 is a schematic view showing the assembly of FIG. 6 afterdeployment of the fixation band's proximal fixation means;

FIG. 8 is a schematic view showing a restraining device for restrainingthe fixation band's proximal fixation mean;

FIGS. 9A-12B are schematic views showing a fixation apparatus havingside deploying barbs;

FIGS. 13A-13D are schematic views showing a heart valve replacementusing the side deploying fixation apparatus shown in FIGS. 9A-12B;

FIGS. 14-30 are schematic views showing fixation apparatus havingcompression deploying barbs; and

FIGS. 31 and 32 are schematic views showing a heart valve replacementusing a left ventrical approach;

FIGS. 33-35 are schematic views showing fixation of an prosthetic aorticheart valve at an annulus of the native aortic valve;

FIGS. 36-39 are schematic views showing fixation of an prosthetic heartvalve using snap fit means; and

FIG. 40 is a schematic view showing another embodiment of a prostheticheart valve using snap fit means.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Looking first at FIG. 1, there is shown a fixation band 5 whichcomprises one preferred form of the invention. Fixation band 5 generallycomprises a tubular frame 10 and a tube 15.

Tubular frame 10 is shown in greater detail in FIG. 2. Tubular frame 10generally comprises a distal end 20 and a proximal end 25. Tubular frame10 comprises a plurality of longitudinally-extending members 30 eachhaving a hook 35 on its distal end, and fixation means 40 (discussed infurther detail below) on its proximal end. Tubular frame 10 alsocomprises at least one laterally-extending member 45 for stabilizing thelongitudinally-extending members 30 relative to one another so as toform the complete tubular frame. In one form of the invention, eachlaterally-extending member 45 extends completely around thecircumference of the frame, in the manner shown in FIG. 2.Alternatively, a series of separate laterally-extending members 45 maybe used to span the circumference of tubular frame 10. Furthermore, inone form of the invention, laterally-extending member 45 may be in theform of a circular hoop, like the hoop of a barrel, such as thelaterally-extending member 47 shown in FIG. 2. Alternatively, and/or inaddition, laterally-extending member 45 may have a serpentineconfiguration, such as the laterally-extending member 48 shown in FIG.2.

Tube 15 is, initially, an ordinary straight tube such as is shown inFIG. 3, i.e., it is a hollow structure having a distal end 50, aproximal end 55 and a central lumen 60 extending therebetween. Tube 15is preferably formed out of material which is easily incorporated intissue, e.g., Dacron polyester or the like. Tube 15 may be verticallypleated or elastic, whereby to allow the material to stretch radially.

Tube 15 is preferably mounted to tubular frame 10 as follows. First, thedistal end 50 of tube 15 is passed, distally, down the interior oftubular frame 10. Then the distal end 50 of tube 15 is everted (FIG. 4)so as to fold it back over, and cover, the hooks 35 oflongitudinally-extending members 30.

As this is done, a sewing cuff 65 is formed in tube 15 distal to thedistalmost end of longitudinally-extending members 30. Tube 15 may thenbe secured in this position, e.g., with sutures 70 maintaining sewingcuff 65 and with sutures 80 holding tube 15 to longitudinally-extendingmembers 30.

In use, a standard prosthetic heart valve 85 (FIG. 5) is secured to thedistal end of fixation band 5 by sewing the prosthetic heart valve'ssewing cuff 90 to the fixation band's sewing cuff 65. Next, theprosthetic valve 85, with fixation band 5 attached, is advanced to thevalve's seat. Then the fixation band's tubular frame 10 is pulledproximally slightly. This action causes the ends of the hooks 35 to passthrough the side wall of the everted tube 15 (FIG. 6) and into thesurrounding tissue T at the valve's seat, whereby fixation band 5, andhence prosthetic valve 85, will be fixed against further proximalmovement. Next, the fixation band's fixation means 40 are deployed (FIG.7) so as to secure the proximal end of the fixation band to surroundingtissue, whereby the fixation band, and hence the prosthetic valve, willbe fixed against distal movement. Where the fixation means 40 aresecured to the proximal end of tube 15, the proximal end of tube 15 willfollow the curvature of the deploying fixation means 40, such as isshown in FIG. 7. Alternatively, if fixation means 40 are free to moveindependently outboard relative to the proximal end of tube 40, eitherbecause they are not secured to tube 15 or they extend past the proximalend of the tube, fixation means 40 are free to move separately into thesurrounding tissue.

In one form of the invention, fixation means 40 may be deployed bybending the proximal ends of longitudinally-extending members 30outwardly, e.g., with an annular forming tool or a forceps-type device.

In another form of the invention, fixation means 40 may be deployed byremoving a restraining device, e.g., a collar 87 (FIG. 8), wherebyfixation means 40 will automatically deploy against the surroundingtissue.

Fixation band 5 may be used to affix prosthetic heart valve 85 to tissuein a conventional on-pump surgical procedure. Alternatively, and morepreferably, fixation band 5 may be used to affix prosthetic heart valve85 to tissue in a beating heart, off-pump surgical procedure. In thiscase, the assembled heart valve 85 and fixation band 5 are advanced tothe intended valve seat by passing the assembly through an appropriatevascular pathway, e.g., in the case of the aortic valve, by passing theassembly down the aorta.

It should be appreciated that various modifications may be made to thepreferred embodiments described above without departing from the scopeof the present invention. Thus, for example, in the foregoingdescription, tubular frame 10 is described as being fully assembled(i.e., laterally-extending member 45 is secured tolongitudinally-extending member 30) prior to being joined with tube 15so as to form the complete fixation band 5. However, it should also beappreciated that longitudinally-extending members 30 and/or thelaterally-extending member 45 may be secured to tube 15 prior to beingjoined to one another.

Furthermore, in the foregoing description, tube 15 is describe as being,prior to eversion, an ordinary straight tube. However, if desired, tubecould be flared outwardly toward its distal end 50 to facilitieseversion over hooks 35, and/or it could include a radially-extendingflange 16 at its distal end to facilitate eversion over hooks 35, wherethe flange 16 may be formed separately from the main body of the tube.

Referring next to FIGS. 9A-13D, there is shown a side deployingapparatus 90 for affixing an prosthetic aortic heart valve 95 inposition inside the aorta. Side deploying apparatus 90 is a multi-statedevice that can be safely guided into the aorta, properly positionednear the annulus of the native aortic valve, and then, by eitherautomatic action or operator control, be deployed by means ofintroducing a number of barbs 100 into the aortic valve annulus. Sidedeploying apparatus 90 may also have the capability of its barbs 100being retracted for either better positioning or removal.

Looking now at FIGS. 9A-9D, in a preferred embodiment of the presentinvention, apparatus 90 comprises two shell portions 105 and two cogportions 110. In FIG. 9A, apparatus 90 is shown assembled and its barbs100 deployed. In FIG. 9B, apparatus 90 is shown assembled, attached to aprosthetic valve 95 and its barbs 100 deployed, which keeps prostheticvalve 95 stationary relative to the wall of the aorta. Three significantfeatures of shell 105 are: studs 115, which act as anchors for cog 110;the exit tracts 120, which allow for barbs 100 of cog 110 to exit shells105; and the pinholes 125 through which actuating pins 130 (FIG. 11B)are inserted.

Looking now at FIGS. 11A and 11B, cog 110 is shown in a “loaded” forminside shell 105. Two cogs 110 are the moving parts of apparatus 90 andreside sandwiched next to each other inside shells 105, but in opposingdirections to one another. Referring again to FIGS. 11A and 11B, cog 110has several significant features integral to its function: eyelets 135,springs 140, barbs 100, and pinholes 142. When in the loaded state,springs 140 of cog 110 are stretched and barbs 100 are folded down whilestuds 115 on shell 105 protrude through eyelets 135 and pins 130 areinserted through pinholes 142 so as to maintain the position of each cog110 relative to shell 105.

Looking now at FIGS. 12A and 12B, cog 110 is shown in the “deployed”form relative to shell 105. Here, barbs 100 are extended through exittracts 120 and springs 140 are no longer stretched. Apparatus 90 can betransformed into the deployed state by removing pins 130 from pinholes142 of each cog 110. When this happens, springs 140 each contract so asto rotate cog 110 relative to studs 115 of shell 105 and force barbs 100out of exit tracks 120. To retract apparatus 90, force on pinholes 142must be re-applied and cog 110 rotated back to its loaded position (seeFIGS. 11A and 11B).

Looking next at FIGS. 13A-13D, there is shown an example of a typicalheart valve replacement. In FIG. 13A, there is shown an aorta 145 with anative aortic valve 150. In FIG. 13B, aorta 145 is shown after valve 150has been removed. In FIG. 13C, side deploying apparatus 90 is shown inan undeployed state (see FIGS. 11A and 11B) inside aorta 145. In FIG.13D, side deploying apparatus 90 is shown in a deployed state (see FIGS.12A and 12B) inside aorta 145.

In the preceding description, side deploying apparatus 90 is describedin the context of affixing an prosthetic heart valve 95 in positionwithin the aortic valve annulus. In this respect it should also beappreciated, however, that side deploying apparatus 90 may be used toaffix some other heart valve within another cardiovascular structure.

Referring now to FIGS. 14-40, there is shown an apparatus 155 (FIG. 14)for affixing an prosthetic aortic valve 160 (FIG. 17) in position insidethe aortic valve annulus. Apparatus 155 is a compressive device that canbe safely guided into the aorta, properly positioned near the annulus ofthe native aortic valve, and then, by either automatic action oroperator control, deployed by means of advancing staples 165 (FIG. 17)into the aortic valve annulus. Compressive apparatus 155 may also havethe capability of having its staples 165 retracted for either betterpositioning or removal of the apparatus. Compressive apparatus 155 maybe positioned for fixation above, below, or at the annulus of the nativeaortic valve. Compressive apparatus 155 may also be positioned using anaortic approach or a left ventricular approach so as to advance ittoward the annulus of the native aortic valve.

Looking now at FIGS. 14-22, in a preferred embodiment of the presentinvention, compressive apparatus 155 comprises a top ring 170 and abottom ring 175 selectively positionable relative to one another byconnector portions 180. Top ring 170 and bottom ring 175 each have asurface, forming an anvil 185, facing one another. In a preferredembodiment of the present invention, each anvil 185 (on top ring 170 andbottom ring 175) is shaped in an opening curve configuration so as toform a “C” shaped staple 165 (see FIG. 19) when deployed. In analternative preferred embodiment of the present invention, each anvil185 is shaped with a closing curve so as to form a “B” shaped staple(not shown) when deployed.

Looking next at FIGS. 17-22, in a preferred embodiment of the invention,apparatus 155 includes deployment means 190 for selectively actuatingtop ring 170 and bottom ring 175 relative to one another. Deploymentmeans 190 generally comprise a handle 195, a plurality of cables 200selectively connected to bottom ring 175 and extending to handle 195,and a support 205 selectively engaging top ring 170 and slidablyconnected to handle 200. In one preferred embodiment of the presentinvention, support 205 (see FIG. 16) comprises a solid component havingpassages 210 for blood flow formed therein. In another preferredembodiment of the invention, support 205 comprises three legs 215 (FIG.17), which allow blood flow therebetween.

Now referring to FIGS. 17-22, in a preferred embodiment of the presentinvention, there is shown the compressive apparatus 155 and theprosthetic aortic heart valve 160 in connection to one another.Preferably, this connection is performed prior to implantation, eitherin an operating room by a physician or a manufacturing site by amanufacturer. In another preferred embodiment of the present invention,apparatus 155 and prosthetic aortic heart valve 160 are connected to oneanother in vivo, either prior to, or subsequent to, the fixation ofapparatus 155 at or adjacent to an annulus of a native aortic heartvalve (not shown).

Looking next at FIGS. 17 and 18, apparatus 155 is shown prior toactuation, with top ring 170 and bottom ring 175 spaced apart from oneanother. While in this configuration, apparatus 155 is positioned at adesired deployment site, at or adjacent to the annulus of the nativeaortic valve (not shown).

Looking next at FIGS. 19 and 20, apparatus 155 is shown subsequent toactuation, with top ring 170 and bottom ring 175 having been broughttoward one another. In this configuration, staples 165 are deployed in a“C” configuration, extending away from each anvil 185, as top ring 170and bottom ring 175 are drawn together. This deployment is effected bymoving handle 195 away from support 205 (while applying a force onsupport 205 to prevent it from also moving with handle 195) so thatcables 200 pull bottom ring 175 toward top ring 170, which is heldstationary by legs 215.

Looking now at FIGS. 21 and 22, deployment means 190 are showndisconnected from apparatus 155 and prosthetic aortic valve 160, withapparatus 155 shown configured for attachment at or adjacent to theannulus of a native aortic heart valve (not shown). Deployment means 190is configured to disengage from apparatus 155 when handle 195 is movedaway from apparatus 155 without holding support 205 stationary; as thisoccurs, cables 200 withdraw from bottom ring 175 and legs 215, which arepivotally attached together, collapse so that they can be withdrawnthrough a narrow opening.

Looking next at FIGS. 23-25, apparatus 155 is shown being actuated by atubular controller 220. Tubular controller 220 generally comprises agrasper 225 for selective attachment to handle 195, and a tube 230surrounding grasper 225 for selectively engaging support 205. Whencompression apparatus 155 is to be deployed (i.e., when it is to haveits rings 170 and 175 drawn together so as to deform the staples 165),tube 230 is held against support 205 while grasper 225 pulls handle 195away from support 205. When deployment means 190 are to be withdrawnfrom compression apparatus 155, tubular controller is withdrawn fromcompression apparatus 155 by simultaneously withdrawing both grasper 225and tube 230.

Referring now to FIGS. 26-29, there is shown apparatus 155 having asingle-anvil 185 for forming staple 165 into a “half-c” configuration.In this embodiment, apparatus 155 may be configured with a height ofabout half that of an apparatus 155 that forms a “C” configuration.

Looking now at FIGS. 30-32, in a preferred embodiment of the presentinvention, there is shown apparatus being placed super-annular, i.e., onthe aorta side of the aortic valve. This placement of apparatus 155superior to the annulus is preferably performed using a left ventricleapproach through the heart. For such a procedure, a collapsible support205 may be used. Alternatively, a non-collapsible support (not shown)may be used. As shown in FIGS. 31 and 32, a punch 235 may be used toresect the native aortic valve, with the punch approaching from either aleft ventricle approach (FIG. 31) or an aortic approach (FIG. 32).

Looking at FIGS. 33-35, in a preferred embodiment of the presentinvention, there is shown apparatus 155 being affixed to the annulus ofthe native heart valve. In this embodiment, staples 165 are placed atthe annulus so as to hold apparatus 155 in place.

Looking next at FIG. 36, a fixation ring 237 is shown with snap fitmeans 238 for attachment of a prosthetic valve 239 to the fixation ring237. Fixation ring 237 is deployed adjacent to the annulus of the nativeaortic valve and prosthesis 239 is snap fit to fixation ring 237 usingsnap fit means 238.

Looking next at FIGS. 37-40, in a preferred embodiment of the presentinvention, there is shown apparatus 155 configured with spring snaps 240for attachment of a prosthesis 245 to apparatus 155. Prosthesis 245 maybe secured to apparatus 155 after attachment of apparatus 155 to theannulus is completed.

In the preceding description, compressive apparatus 155 is described inthe context of affixing a prosthetic heart valve in position within theaorta. In this respect it should be appreciated, however, thatcompressive apparatus 155 may be used to affix some other heart valvewithin another cardiovascular structure.

Still other modifications and variations will be apparent to thoseskilled in the art in view of the present disclosure, and are consideredto be within the scope of the present invention.

What is claimed is:
 1. A prosthetic heart valve comprising: a tube defining a proximal end, a distal end, and a central lumen; a tubular frame being disposed on an outside wall of the tube, the tubular frame comprising: a plurality of longitudinally-extending members, each having a hook at a distal end thereof; and at least one laterally-extending member fixed to the longitudinally-extending members, the laterally-extending member extending circumferentially relative to the longitudinally-extending members; the distal end of the tube being everted around the distal end of the tubular frame and extending proximally along the tubular frame and over the hooks to be engaged thereby; wherein the distal end of the tube comprises a radially-extending flange; wherein one laterally-extending member is at least partially positioned outside of the tube; and a valve member attached to the tube.
 2. The prosthetic heart valve of claim 1 wherein the hooks are configured to secure the tubular frame to tissue.
 3. The prosthetic heart valve of claim 1 wherein the at least one laterally-extending member comprises a circular hoop configuration.
 4. The prosthetic heart valve of claim 1 wherein the at least one laterally-extending member comprises a serpentine configuration.
 5. The prosthetic heart valve of claim 1 wherein the distal end of the tube is flared outwardly.
 6. A prosthetic heart valve comprising: a tube defining a proximal end, a distal end, and a central lumen; a tubular frame defining a proximal end, a distal end, and a central lumen, the tubular frame being disposed on an outside wall of the tube the tubular frame comprising: a plurality of longitudinally-extending members, each having a hook at a distal end thereof; wherein the proximal end of each longitudinally-extending member comprises a fixation element for securing the tubular frame to tissue; and at least one laterally-extending member fixed to the longitudinally-extending members, the laterally-extending member extending circumferentially relative to the longitudinally-extending members; the distal end of the tube being everted around the distal end of the tubular frame and extending proximally along the tubular frame and over the hooks to be engaged thereby; wherein one laterally-extending member is at least partially positioned outside of the tube; and a valve member attached to the tube.
 7. The prosthetic heart valve of claim 6 wherein the fixation element is configured to be bent radially outward to engage tissue.
 8. The prosthetic heart valve of claim 6 further comprising a restraining device, wherein the fixation element is adapted to be deployed by removing the restraining device, whereby the fixation element automatically deploys to engage tissue.
 9. A prosthetic heart valve comprising: a tube defining a proximal end, a distal end, and a central lumen; a tubular frame defining a proximal end, a distal end, and a central lumen, the tubular frame being disposed on an outside wall of the tube, the tubular frame further comprising a plurality of radially-extending members; wherein the tubular frame further comprises a plurality of longitudinally-extending members having a distal end and a proximal end; wherein the proximal end of each longitudinally-extending member is positioned outside of the everted tube; wherein the tubular frame further comprises at least one laterally-extending member fixed to the longitudinally-extending members, the laterally-extending member extending circumferentially relative to the longitudinally-extending members; wherein the proximal end of each longitudinally-extending member comprises a fixation element for securing the tubular frame to tissue; the distal end of the tube being everted around the distal end of the tubular frame and extending proximally along the tubular frame and over the radially-extending members; wherein the tubular frame is at least partially positioned outside of the everted tube; and a valve member attached to the tube.
 10. The prosthetic heart valve of claim 9 wherein the at least one laterally-extending member comprises a circular hoop configuration.
 11. The prosthetic heart valve of claim 9 wherein the at least one laterally-extending member comprises a serpentine configuration.
 12. The prosthetic heart valve of claim 9 wherein the fixation element is configured to be bent radially outward to engage tissue.
 13. The prosthetic heart valve of claim 9 further comprising a restraining device, wherein the fixation element is adapted to be deployed by removing the restraining device, whereby the fixation element automatically deploys to engage tissue.
 14. The prosthetic heart valve of claim 9 wherein each radially-extending member comprises a hook configured to secure the tubular frame to tissue.
 15. The prosthetic heart valve of claim 9 wherein the distal end of the tube is flared outwardly.
 16. The prosthetic heart valve of claim 9 wherein the distal end of the tube comprises a radially-extending flange. 